The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0956-2020·Announced 2020-02-19

Medtronic MiniMed 670G System Recalled for Loose Insulin Reservoir

Medtronic is recalling MiniMed 670G Systems with SmartGuard because a broken or missing retainer ring can cause the insulin reservoir to become loose, leading to incorrect insulin delivery.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly…"

Plain-English summary

Medtronic Inc. is recalling the Medtronic MiniMed 670G System with SmartGuard. The recall affects specific model numbers, including MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, and MMT-1782. The devices are identified by all serial numbers, excluding those with black retainer rings. The product was distributed in the United States and various international locations.

The recall is due to reported incidents where the insulin reservoir becomes loose and can no longer be locked into the pump. This issue occurs when the retainer ring is broken or missing, preventing a proper lock. If the reservoir is not properly locked, it may result in the over-delivery or under-delivery of insulin. This malfunction can lead to hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar).

Consumers should contact Medtronic for instructions on how to address the issue. The source text does not specify the number of affected units or the exact number of reported incidents.

The recalled product

Product
Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, and MMT-1782
Manufacturer
Medtronic Inc.
Category
Medical Device — Insulin Pump
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Serial Numbers ( excluding devices with black retainer rings)

Distribution

Distributed in 52 states:

Part of a larger recall action

This product is one of 4 recalled by Medtronic Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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